JETSTREAM G3 SE SYSTEM, JETSTREAM G3 SF SYSTEM MODEL PV31230 (JETSTREAM G3 SE CATHETER AND CONTROL POD); PVCN100 (PV CON

K101334 · Pathway Medical Technologies, Inc. · MCW · Jun 11, 2010 · Cardiovascular

Device Facts

• Record ID: K101334
• Device Name: JETSTREAM G3 SE SYSTEM, JETSTREAM G3 SF SYSTEM MODEL PV31230 (JETSTREAM G3 SE CATHETER AND CONTROL POD); PVCN100 (PV CON
• Applicant: Pathway Medical Technologies, Inc.
• Product Code: MCW · Cardiovascular
• Decision Date: Jun 11, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4875
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Jetstream System is intended for use in atherectomy of the peripheral vasculature and to break apart and remove thrombus from upper and lower extremity peripheral arteries. It is not intended for use in coronary, carotid, iliac or renal vasculature.

Device Story

Jetstream G3 SE and SF systems are atherectomy catheters for debulking and treating peripheral vascular disease. System components include a sterile, single-use catheter with a differentially cutting tip and a reusable console. The catheter features integrated lumens for continuous aspiration of excised tissue/thrombus and infusion of sterile saline. The console houses peristaltic pumps, a system controller, and a keypad interface. During procedures, the catheter is inserted into the peripheral vasculature; the console remains outside the sterile field. The device uses mechanical cutting to break apart thrombus and plaque, which are then aspirated into a collection bag. The G3 SE model includes expandable cutting blades, while the G3 SF model uses a fixed-diameter cutter. The system provides clinicians with real-time operational status via LED indicators. By removing obstructive material from peripheral arteries, the device aims to restore blood flow and improve patient outcomes.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included dimensional verification, catheter burst/pull strength, system reliability, infusion/aspiration flow rates, torque to failure, trackability, aspiration efficiency, crossing time, heat generation, rotational speed, guidewire/device wear, sterilization validation, control pod logic verification, and electrical safety.

Technological Characteristics

System consists of an electrically driven catheter with a differentially cutting tip and a reusable console with two peristaltic pumps. Materials include standard medical-grade components. Connectivity includes electrical connectors for the control pod and console. Sterilization is performed via Ethylene Oxide (EO). Software includes control pod logic for device operation. Dimensions modified for smaller crossing profile compared to predicates.

Indications for Use

Indicated for atherectomy and thrombus removal in upper and lower extremity peripheral arteries. Contraindicated for use in coronary, carotid, iliac, or renal vasculature.

Regulatory Classification

Identification

An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)

Predicate Devices

• Jetstream G3TM System (K100462)
• Jetstream G3TM System (K093456)
• Jetstream G3TM System (K092332)
• Jetstream G2TM NXT System (K091509)
• Jetstream Pathway PVTM Atherectomy System (K082186)
• Pathway PVTM Atherectomy System (K081328)

Submission Summary (Full Text)

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K101334

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JUN 1 1 2010

## 510(k) SUMMARY

General Information: Date of Summary Preparation:

June 4, 2010

Name and Address of Manufacturer:

Pathway Medical Technologies, Inc. 10801 120th Ave NE Kirkland, Washington 98033

Contact Person:

Trade Name:

Common Name:

Regulation Number:

Regulation Name:

Regulatory Class:

Classification Panel:

Product Code:

Cyndy Adams Regulatory Affairs Sr. Manager Phone: [phone] Fax: [phone]

Jetstream G3TM SE System Jetstream G3TM SF System

Peripheral Atherectomy Catheter

21 CFR 870.4875

Intraluminal Artery Stripper

Class II

Cardiovascular

MCW

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Performance Standards: Performance standards do not currently exist for these devices. None are established under Section 514.

Device Description: The Jetstream G3 SE and Jetstream G3 SF Systems are atherectomy catheter devices intended for use in debulking and treating vascular disease in the peripheral vasculature. The Jetstream G3 SE System is designed with expandable cutting blades; the Jetstream G3 SF System has only a fixed diameter cutter; that is, it does not incorporate the expandable blades. Separate lumens within the Catheters allow for continuous aspiration and infusion during device use. Excised tissue, thrombus, and fluid are aspirated from the peripheral treatment site through a port in the Catheter tip to a collection bag located on the Console. The distal portion of the Catheter also possesses infusion ports that provide continuous infusion of sterile saline during the atherectomy procedure.

The Jetstream G3 SE and G3 SF Systems each consist of two primary components: (1) a Catheter with Control Pod and (2) a Console, which are packaged separately. Each of these system components is described generally as follows:

- Catheter with Control Pod: A sterile, single-use unit consisting of an . electrically driven Catheter and Control Pod. The Catheter utilizes a differentially cutting tip and includes both aspiration and infusion capabilities. The Control Pod provides a user interface with keypad controls. The unit, its electrical connectors, tubing, and aspirant collection bag are packaged in a double-pouched tray.
- . PV Console: A reusable compact Console, with two (2) peristaltic pumps for aspiration and infusion, power supply, system controller, keypad interface, and LED indicators for device operational status. The Console mounts on a standard I.V. stand and remains outside the sterile field during the procedure.

This 510(k) is for the same device most recently cleared under 510(k) K093456, but with a slightly increased catheter length and decreased catheter and tip diameter to achieve a slightly smaller crossing profile. The motor gear ratio is changed and the expandable blades are eliminated from one of the device models.

Indications for Use: The Jetstream System is intended for use in atherectomy of the peripheral vasculature and to break apart and remove thrombus from upper and lower extremity peripheral arteries. It is not intended for use in coronary, carotid, iliac or renal vasculature.

Substantially Equivalent Devices: Pathway Medical cites the following as substantially equivalent predicate devices:

- · Jetstream G3TM System (K100462)
- · Jetstream G3TM System (K093456)
- · Jetstream G3TM System (K092332)
- · Jetstream G2TM NXT System (K091509)

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- · Jetstream Pathway PVTM Atherectomy System (K082186)
- · Pathway PVTM Atherectomy System (K081328)

Testing Summary: To demonstrate substantial equivalence of the Jetstream G3 SE and Jetstream G3 SF Systems with the predicate devices, the technological and performance characteristics were evaluated using in vitro testing as outlined below:

- . Dimensional Verification
- Catheter Burst .
- . Catheter Pull
- System Reliability/Life .
- Speed Drop Flexibility .
- Accessory Compatibility .
- Infusion and Aspiration Flow Rates .
- . Torque to Failure
- Catheter Trackability and Pushability .
- Aspiration Efficiency and Crossing Time ◆
- Heat Generation .
- Rotational Speed .
- Guidewire and Device Wear .
- Sterilization (EO) Validation .
- Control Pod Logic Verification .
- Electrical Safety .

The results from these tests:

- demonstrate that the technological and performance characteristics of the . ﺮ Jetstream G3 SE and Jetstream G3 SF Systems are comparable to those of the predicate devices.
- . support the safety and effectiveness of the modifications that are the subject of this 510(k), and
- ensure the modified devices can perform equivalently to the listed predicate . devices, which have the identical intended use.

Conclusion (Statement of Equivalence): The data and information presented within this submission and the similarities between the modified and predicate devices, support the substantial equivalence of the Jetstream G3 SE and Jetstream G3 SF Systems to the specified predicate devices. The devices have identical indications for use and equivalent technological characteristics. Bench testing supports the safety and effectiveness of the modifications that were the subject of this 510(k).

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a bird-like figure, which is the department's official emblem.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

JUN 1 1 2010

Pathway Medical Technologies, Inc. c/o Mr. Brian Cleary Vice President of Clinical and Regulatory Affairs 10801 120th Ave NE Kirkland, WA 98033

Re: K101334

Trade/Device Name: Jetstream G3 SE & SF Systems Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal Artery Stripper Regulatory Class: Class II (two) Product Code: MCW Dated: May 11, 2010 Received: May 12, 2010 Amended: June 4, 2010

Dear Mr. Cleary:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 -- Mr. Brian Cleary

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

W. Ward

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K101334

Device Names: Jetstream G3TM SE System Jetstream G3TM SF System

## Indications for Use:

.

The Jetstream System is intended for use in atherectomy of the peripheral vasculature and to break apart and remove thrombus from upper and lower extremity peripheral arteries. It is not intended for use in coronary, carotid, illiac or renal vasculature.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

W. Mac.

(Division Sign-Off) Division of Cardiovascular Devi

510(k) Number

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